MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SUCTION VALVE

Model Number	MAJ-207
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Ectopic Heartbeat (4443); Respiratory Insufficiency (4462)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the suction button/valve suddenly broke and could not be removed from the endoscope during a bronchoscopy procedure.As such, the procedure/examination was interrupted and the patient presented with chest tightness, respiratory insufficiency and arrhythmia.The procedure was able to be completed with a similar device with a delay of 20 minutes.Follow-up information for the event is pending at the time of the report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information provided through follow up (b5).Since the actual product was not sent, reproducibility was confirmed using a sample from a different lot (h9z25).As a result, if the rubber valve was attached correctly, no rubber valve remained inside the scope's suction cylinder.It was also confirmed that if the rubber valve was attached incorrectly, it would come off and remain inside the scope's suction cylinder.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the reported event occurred due to maj-207 (suction valve) detached from the endoscope, and the rubber valve of maj-207 remained inside the suction cylinder of the endoscope.Furthermore, it is possible maj-207 became detached from the endoscope due to the subject device not being properly attached to the endoscope and/or the rubber valve is not assembled properly with maj-207 main body.However, the subject device was not returned, and the specific root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: -6.1 attaching the suction valve to the endoscope."(warning) firmly attach the suction valve to the suction cylinder of the endoscope.If the suction valve is attached to the endoscope improperly with a gap between the base of the suction valve and the top of the suction cylinder, the suction valve may detach from the endoscope and/or may cause patient debris to leak or spray from the gap, posing an infection-control risk." "sometimes the suction valve will click before it is fully seated in the suction cylinder.Press the suction valve down firmly to ensure that it is fully seated in the suction cylinder." - 8 assembling and inspecting the suction valve "8.1 assembling the suction valve 1.Press the valve into the main body 2.Inspection after assembling 3.Verify that the valve is correctly attached to the main body.4.Visually inspect the valve and the spring for cracks." olympus will continue to monitor field performance for this device.
Event or Problem Description
Information inadvertently left out: it was reported that faulty maj-207 (suction valve) has been abandoned.The device malfunction occurred during a diagnostic procedure and the faulty equipment did not fall into the body.There were no effects on the patient, and no injuries occurred.The patient has been discharged from the hospital.Additionally, the patient's outcome due to the procedure was not affected.
Additional Manufacturer Narrative
This report is being supplemented to provide correction to the pervious report with information inadvertently left out (b5).

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20707761
• Report Number: 3003637092-2024-00188
• Device Sequence Number: 15854114
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 03/04/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/09/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOVIDEOSCOPE, BF-1T260, SN- (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown